Administrative information
Data category
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Information
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Title | Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership’s home visiting program in South Carolina on maternal and child health outcomes |
Trial Registration: | AEA RCT Registry: AEARCTR-0001039 Clinicaltrials.gov: NCT03360539 |
Primary registry and trial identifying number | AEA RCT Registry: AEARCTR-0001039 |
Date of registration in primary registry | February 20, 2016 |
Secondary identifying numbers | ClinicalTrials.gov: NCT03360539 |
Source(s) of monetary or material support | Children’s Trust of South Carolina, Arnold Ventures, The Duke Endowment, The BlueCross BlueShield Foundation of South Carolina |
Primary sponsor | Harvard T.H. Chan School of Public Health |
Secondary sponsor(s) | Abdul Latif Jameel Poverty Action Lab; University of Chicago |
Contact for public queries | Margaret McConnell
mmcconne@hsph.harvard.edu
|
Contact for scientific queries | Margaret McConnell
mmcconne@hsph.harvard.edu
|
Public title | Nurse-Family Partnership Impact Evaluation in South Carolina (NFP) |
Scientific title | Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership’s home visiting program in South Carolina on maternal and child health outcomes |
Countries of recruitment | United States of America |
Health condition(s) or problem(s) studied | Preterm Birth; Injuries; Maternal Behavior |
Intervention(s) | Experimental: Treatment—Nurse-Family Partnership prenatal and infancy home visiting program providing with regular visits to first-time mothers until the child is two years old |
No intervention: Control group members have access to the standard of care | |
Key inclusion and exclusion criteria | Ages Eligible for Study: 15–55 Years; Sexes Eligible for Study: Female; Accepts Healthy Volunteers: Yes |
Inclusion Criteria: Female; No previous live births; Currently pregnant; Gestation period less than 28 weeks (i.e., less than or equal to 27 weeks, 6 days) at time of recruitment; Ages 15–55; Income level meets Medicaid eligibility criteria; Live within an area serviced by a NFP Implementing Agency; Not currently enrolled in the study; Not incarcerated or living in lock down facilities | |
Exclusion Criteria: Men; Women who have had a previous live birth; Women who are not currently pregnant; Women who are past their 28th week of gestation (i.e., greater than or equal to 28 weeks, 0 days) at time of recruitment; Women who are younger than 15 or older than 55 years of age; Women whose income level does not meet Medicaid eligibility criteria; Women who live outside of an area serviced by a NFP Implementing Agency; Women who are currently enrolled in the study; Women who are currently incarcerated or living in a lock down facility | |
Study type | Allocation: Randomized Intervention model: Single Group Assignment Masking: None (Open Label) Primary purpose: Supportive Care |
Date of first enrolment | April 1, 2016 |
Target sample size | 6000 participants |
Recruitment status | Closed |
Primary outcome(s) | Composite of Small for gestational age, or Low birth weight (less than 2500 g), or Preterm Birth (less than 37 weeks’ gestation by obstetric estimate) or Perinatal Mortality (fetal death at or after 20 weeks of gestation or mortality within first 7 days of life) [Time Frame: Captured by birth certificates at birth (Jan 2021)] Composite of either major injury or concern for abuse or neglect [Time Frame: Captured by Medicaid claims, hospital discharge at 24 months postpartum] Inter-birth interval of < 21 months [Time Frame: Captured by birth certificates at 21 months (October 2022)] |
Key secondary outcomes | Small for gestational age [Time Frame: Captured by birth certificates at 0 months (Jan 2021)] (See Table 1 for complete list of secondary outcomes) |
Protocol version | Issue date: January 30, 2020 Protocol amendment number: 02 Authors: MAM,1 AZ,2 MWM,3 RG,4 MS,5 MB,6 CZ,7,9 MH,8,9,10 AC,11,12 KB2,6,13 Revision chronology: August 19, 2015—Original Draft January 30, 2020—Draft for first journal submission October 21, 2020—Draft responding to reviewer comments |
Author details | Authors: MM,1 AZ,2 MWM,3 RG,4 MS,5 MB,6 CZ,7,9 MH,8,9,10 AC,11,12 KB2,13 1 Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 2 National Bureau of Economic Research (NBER), Cambridge, MA 3 Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA 4 Department of Health Care Policy, Harvard Medical School, Boston, MA 5 Populations Studies and Training Center, Brown University, Providence, RI 6 Abdul Latif Jameel Poverty Action Lab (J-PAL), Cambridge, MA 7 Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA 8 Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA 9 Department of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Boston, MA 10 Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 11 Department of Pediatrics, Harvard Medical School, Harvard University, Boston, MA 12 Department of Medicine, Boston Children’s Hospital, Boston, MA 13 University of Chicago Harris School of Public Policy, Chicago, IL Authors’ contributions: AZ, MWM, MB, KB: Conception and development MAM, AZ, MWM, MB, KB: Study design MAM, MWM, RG, MS, CZ, MH, AC: Design of outcomes MAM: Original Draft of manuscript MAM, AZ, MWM, RG, MS, MB, CZ, MH, AC, KB: Editing and review of manuscript and approval of final version |
Trial sponsor | Trial Sponsor: Harvard T.H. Chan School of Public Health Sponsor’s Reference: FWA00002642 Contact name: Margaret McConnell, PhD Address: 677 Huntington Avenue, Boston Massachusetts Telephone: (203)745-8321 Email: mmcconne@hsph.harvard.edu |
Role of study sponsor and funders | The research team received feedback on the proposed research from the Pay for Success (PFS) contract signatories (including the Nurse-Family Partnership) and the funders that informed the approach to outcome selection and the definition of subgroups. PFS signatories and funders will have no influence on the analysis of data or reporting of results. |
Other roles | The Abdul Latif Jameel Poverty Action Lab has led the implementation of the trial. Sam Ayers, Adam Baybutt, Kim Gannon, Noreen Giga, Elisabeth O’Toole and Pauline Shoemaker all contributed substantially to the development and implementation of the trial. |
Background
Addressing the challenges of childhood poverty with community-based medicine
Nurse-Family Partnership model
Context of the South Carolina trial
Protocol paper focus: maternal and child health outcomes during pregnancy and early childhood
Methods
Ethical considerations
Intervention: Nurse-Family Partnership program
Pay for success background
NFP program implementation in South Carolina
Eligibility criteria
Referral
Enrollment and informed consent
Randomization
Data sources
Baseline survey
Survey of nurses
Administrative data sources and matching to outcomes
NFP theory of change and program content
Existing evidence base on NFP services
Primary study outcomes
Data source(s) | Time at complete outcome observation (time since all pregnancies completed) | |
---|---|---|
Objective 1. Improve pregnancy, birth, and maternal health outcomes | ||
Primary outcome | ||
Composite of at least one of: • Small for gestational age, or • Low birth weight (less than 2500 g), or • Preterm birth (less than 37 weeks’ gestation by obstetric estimate), or • Perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life) | Birth certificates, fetal death records, mortality records | 1 months (Feb 2021) |
Secondary outcomes | ||
Infant outcomes observed at birth | ||
Small for gestational age | Birth certificates | 0 months (Jan 2021) |
Large for gestational age | Birth certificates | 0 months (Jan 2021) |
Low birth weight (< 2500 g) | Birth certificates | 0 months (Jan 2021) |
Very low birth weight (< 1500 g) | Birth certificates | 0 months (Jan 2021) |
Birth weight (continuous) | Birth certificates | 0 months (Jan 2021) |
Preterm birth (< 37 weeks’ gestation by obstetric estimate)1 | Birth certificates | 0 months (Jan 2021) |
Extremely preterm (< 28 weeks’ gestation) | Birth certificates | 0 months (Jan 2021) |
Gestational age at birth in weeks (continuous) | Birth certificates | 0 months (Jan 2021) |
Perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life) | Fetal death records, mortality records | 1 months (Feb 2021) |
NICU admission of at least overnight | Hospital discharge | 0 months (Jan 2021) |
Neonatal morbidity2 | Hospital discharge | 0 months (Jan 2021) |
Maternal outcomes | ||
Cesarean delivery | Birth certificates | 0 months (Jan 2021) |
Severe acute maternal morbidity3 | Hospital discharge | 0 months (Jan 2021) |
Maternal mortality (up to 1 year after birth) | Mortality records | 12 months (Jan 2022) |
Neonatal abstinence disorder or maternal drug/substance abuse | Medicaid claims, hospital discharge | 24 months (January 2023) |
Maternal experience of violence or homicide4 | Medicaid claims, mortality records | 24 months (January 2023) |
Postpartum visit within the first 12 weeks postpartum | Medicaid claims | 2 months (March 2021) |
Utilization and quality of prenatal care | ||
Adequate prenatal care (Adequacy of Prenatal Care Utilization (APNCU) Index) | Birth certificates | 0 months (Jan 2021) |
Number of emergency department visits during pregnancy | Hospital discharge | 0 months (Jan 2021) |
Dental visit (preventive or treatment) during pregnancy | Medicaid medical and dental claims | 0 months (Jan 2021) |
Ultrasound at 18–22 weeks (anatomy scan) | Medicaid claims | 0 months (Jan 2021) |
Proportion of recommended prenatal screenings completed5 | Medicaid claims | 0 months (Jan 2021) |
Mental health outcomes | ||
Any outpatient treatment or diagnosis6,7 | Medicaid claims | 2 months (March 2021) |
Diagnosis of depression/anxiety/stress reaction6 | Medicaid claims | 2 months (March 2021) |
Antidepressant prescription6 | Medicaid claims | 2 months (March 2021) |
Outpatient mental health visit6 | Medicaid claims | 2 months (March 2021) |
Treatment follow-up8 | Medicaid claims | 6 months (July 2021) |
Mental health-related emergency/inpatient visit9 | Hospital discharge | 12 months (January 2022) |
Number of mental health-related emergency/impatient visits9 | Hospital discharge | 12 months (January 2022) |
Objective 2. Improve child health and development | ||
Primary outcome | ||
Composite of at least one health care encounter or mortality associated with ICD codes indicating at least one of the following: • Major injury, or • Concern for abuse or neglect | 24 months (January 2023) | |
Secondary outcomes | ||
Accidents, suspected abuse and neglect and emergency care utilization | ||
Health care encounter or mortality associated with ICD codes indicating major injury | Medicaid claims, hospital discharge, mortality files (defined in Table 2) | 24 months (January 2023) |
Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect | Medicaid claims, hospital discharge, mortality files (defined in Table 3) | 24 months (January 2023) |
Number of injuries10 | Hospital discharge | 24 months (February 2023) |
Any emergency department visit | Hospital discharge | 24 months (January 2023) |
Number of emergency department visits | Hospital discharge | 24 months (January 2023) |
All-cause child mortality in first 24 months of life or fetal death | Fetal death records, mortality records | 24 months (January 2023) |
Outcomes related to preventative care | ||
Proportion of recommended well-child visits | Medicaid claims | 15 months (April 2022) |
At least one lead screening | Medicaid claims | 15 months (April 2022) |
At least one developmental screening11 | Medicaid claims | 12 months (January 2022) |
At least one dental visit12 | Medicaid medical and dental claims | 24 months (January 2023) |
Share of recommended fluoride treatments13 | Medicaid medical and dental claims | 24 months (January 2023) |
Objective 3. Alter maternal life course | ||
Primary outcome | ||
Inter-birth interval of < 21 months | Birth certificates | 21 months (October 2022) |
Secondary outcomes | ||
Birth spacing outcomes | ||
Inter-birth interval of < 24 months14 | Birth certificates | 24 months (January 2023) |
Inter-birth interval of < 15 months | Birth certificates | 15 months (April 2022) |
Inter-birth interval (continuous) | Birth certificates | 60 months (January 2026) |
Postpartum family planning while enrolled in postpartum Medicaid coverage (6 weeks) | ||
Any family planning related counseling or service | Medicaid claims, hospital discharge15 | 6 weeks (March 2021) |
Received a highly or moderately effective method of contraception16 | Medicaid claims, hospital discharge | 6 weeks (March 2021) |
Immediate postpartum long-acting reversible contraception | Medicaid claims, hospital discharge | 6 weeks (March 2021) |
Postpartum family planning within 1 year | ||
Any family planning related counseling or service | Medicaid claims, hospital discharge | 12 months (January 2022) |
Received a highly or moderately effective method of contraception16 | Medicaid claims, hospital discharge | 12 months (January 2022) |
Postpartum intrauterine device insertion | Medicaid claims, hospital discharge | 12 months (January 2022) |
Timing of postpartum family planning take-up | ||
Time to first family planning counseling or service (months from pregnancy) | Medicaid claims, hospital discharge | 24 months (January 2023) |
Time to first utilization of highly effective contraceptive methods (months from discharge) | Medicaid claims, hospital discharge | 24 months (January 2023) |
ICD-10-CM Code | Code description | ICD-10 exclusion codes |
---|---|---|
S00-S09 | Injuries to the head | S00-S00.9 (Superficial injuries of the head) |
S10-S19 | Injuries to the neck | S10-S10.9 (Superficial injuries of the neck) |
S20-S29 | Injuries to the thorax | S20-S20.8 (Superficial injuries of the thorax) |
S30-S39 | Injuries to the abdomen, lower back, lumbar spine, and pelvis | S30-S30.9 (Superficial injuries of the abdomen, lower back, and pelvis) |
S40-S49 | Injuries to the shoulder and upper arm | S40-S40.9 (Superficial injuries of the shoulder and upper arm) |
S50-S59 | Injuries to the elbow and forearm | S50-S50.9 (Superficial injuries of the elbow and forearm) |
S60-S69 | Injuries to the wrist and hand | S60-S60. 9 (Superficial injuries of the wrist and hand) |
S70-S79 | Injuries to the hip and thigh | S70-S70.9 (Superficial injuries of the hip and thigh) |
S80-S89 | Injuries to the knee and lower leg | S80-S80.9 (Superficial injuries of the knee and lower leg) |
S90-S99 | Injuries to the ankle and foot | S90-S90.9 (Superficial injuries of the ankle and foot) |
T00-T07 | Injuries involving multiple body regions | T00-T00.9 (Superficial injuries involving multiple body regions) |
T08-T14 | Injuries to unspecified part of trunk, limb, or body region | T09.0 (Superficial injury of the trunk) |
T15-T19 | Effects of foreign body entering through natural orifice | |
T20-T32 | Burns and corrosions | |
T33-T35 | Frostbite | |
T36-T50 | Poisoning by drugs, medicaments and biological substances | |
T51-T65 | Toxic effects of substances chiefly nonmedicinal as to source | |
T66-T78 | Other and unspecified effects of external causes | T78 (Allergies) |
T79 | Certain early complications of trauma |
ICD-9-CM Code | Code description |
---|---|
054.1, 098 | Genital herpes, Gonococcal infection |
995.50†, 995.54†, 995.55†, 995.59† | Child physical abuse; Shaken baby syndrome; Other child abuse and neglect, not otherwise specified |
262 | Other severe malnutrition |
362.81 | Retinal hemorrhage |
521.0 | Dental caries |
614.9 | Pelvic inflammatory disease, unspecified |
692.7 | Solar radiation dermatitis |
800†, 805†, 807.0†, 807.1†, 808†, 811† | Skull vault fracture; Vertebral fracture; Rib Fracture; Pelvic fracture; Scapula fracture |
852.0†, 852.2†, 852.2† | Traumatic subarachnoid hemorrhage; Traumatic subdural hemorrhage; Other/unspecified intracranial hemorrhage |
860† | Traumatic pneumohemothorax |
861†, 862† | Heart or lung injury; intrathoracic injury, not elsewhere classified |
863.1†, 863.2†, 863.3†, 863.8† | Stomach injury; Small intestine injury; GI injury not elsewhere classified |
864† | Liver injury |
865† | Spleen injury |
866† | Kidney injury |
922.4 | Contusion of genital organs |
941†, 942†, 945†, 946† | Burn of head: Burn of trunk; Burn of leg; Burn of multiple sites |
952† | Spinal cord injury |
960–979† | Poisoning by drugs/medicinals |
994.1† | Drowning, non-fatal submersion |
E869.4 | Second-hand tobacco smoke |
E910.2, E910.4, E910.8, E910.9 | Swimming accident, Bathtub (near) drowning, Other (near) drowning, Accidental (near) drowning, not otherwise specified |
E960.0; E961; E962; E963; E964; E965; E966; E967; E968.0; E968.1; E968.2; E968.3, E968.4, E968.5, E968.6, E968.7, E968.8, E968.9, E980, E985, E988, V60, V71.5, V71.81 | Unarmed fight, brawl; Assault by corrosive or caustic substance, except poisoning; Assault by poisoning; Assault by hanging and strangulation; Assault by submersion; Assault by firearms and explosives; Assault by cutting and piercing instrument; Perpetrator of child and adult abuse; Assault by fire; Assault by pushing from a high place; Assault by striking by blunt or thrown object; Assault by hot liquid; Assault by criminal neglect; Assault by transport vehicle; Assault by air gun; Assault by human bite; Assault by other specified means; Assault by unspecified means; Undetermined intent, poisoning; Undetermined intent, firearm; Undetermined intent, other means; Household circumstances; Observation after alleged rape; Observation for abuse/neglect |
Subgroup analysis
Attrition
Planned analyses
Statistical power
Primary outcomes | Assumptions regarding control group mean | Full sample (unadjusted) | Full sample (Bonferroni) | Vulnerable subgroup (unadjusted) | Vulnerable subgroup (Bonferroni) | ||||
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Low attrition | High attrition | Low attrition | High attrition | Low attrition | High attrition | Low attrition | High attrition | ||
Adverse birth outcome | 24% | − 3.5 pp. (14%) | − 3.6 pp. (15%) | − 4.3 pp. (18%) | − 4.4 pp. (18%) | − 5.2 pp. (21%) | − 5.4 pp. (22%) | − 6.3 pp. (26%) | − 6.6 pp. (27%) |
Birth spacing | 13% | − 2.7 pp. (20%) | − 2.8 pp. (21%) | − 3.3 pp. (25%) | − 3.4 pp. (26%) | − 3.9 pp. (30%) | − 4.1 pp. (31%) | − 4.8 pp. (36%) | − 5.0 pp. (38%) |
Acute injury, abuse or neglect | 18% | − 3.1 pp. (17%) | − 3.2 pp. (18%) | − 3.8 pp. (21%) | − 3.9 pp. (22%) | − 4.6 pp. (26%) | − 4.7 pp. (26%) | − 5.6 pp. (31%) | − 5.8 pp. (32%) |